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Effect of Preoperative Music on Sterile Inflammation Induced by Laparoscopic Surgery

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ClinicalTrials.gov Identifier: NCT03429478
Recruitment Status : Recruiting
First Posted : February 12, 2018
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
PROF. BRIJ B AGARWAL, Sir Ganga Ram Hospital

Brief Summary:
Surgery induced sterile inflammation leaves behind a biomolecular footprint measurable by various pro-inflammatory markers e.g. IL-6, CD(Cluster of differentiation)19B, HsCRP(High-sensitivity CRP) etc. Music is a non-pharmacological means in attenuating this inflammatory pathway thereby improving Health related quality of life measurable by improved postoperative convalescence. Correct timing of music application is a lacuna in the knowledge. This research aims at evaluating the effect of preoperative music on sterile inflammation induced by index Laparoscopic Surgery (Laparoscopic Cholecystectomy) and its proposed beneficial effects on patient reported outcomes. A total of 50 patients divided into 2 groups (test and control) will be evaluated in this triple blind randomized controlled study aiming at evaluating the biomolecular signatures of sterile inflammatory response and its correlation with improved postoperative convalescence. All the patients will be followed up for a period of 1 month postoperatively to assess for overall improvement in health related quality of life. Collected data will be analysed using updated SPSS software and a p value of less than 0.05 will be taken as statistically significant in support of the measured indices.

Condition or disease Intervention/treatment Phase
Music Therapy Cholecystitis/Cholelithiasis Inflammatory Response Surgical Injury Other: Preoperative application of a bluetooth enabled Headphones. Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 50 patients meeting the inclusion criteria will be included in the study after written and informed consent. They will be randomized and divided into 2 groups. Group 1 will be labelled as intervention group (recieving pre-operative music intervention), The group 2 will be labelled as controlled group (Not receiving pre-operative music intervention). Clinico-biochemical, Bio-cellular & Neurohumoral data evaluation will be done in both the groups.The results will be analyzed using standard SPSS software.
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description: The Participants will be randomized to be part of the study groups. The Care providers will not be aware of the grouping of the participants as the intervention is done in the pre-operative holding area. All patients will undergo Laparoscopic Cholecystectomy under standard operative and anesthesia protocol. The Investigator (Nurse and the doctor staff) will also be unaware of the grouping of the patients. The recorded data will be analyzed by an individual outcome asser unaware of the grouping or identity of the patient.
Primary Purpose: Basic Science
Official Title: Effect of Preoperative Music on "Sterile Inflammation" Induced by Laparoscopic Surgery-A Randomized Study
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Experimental: Music
Preoperative application of a Bluetooth enabled headphones with standard music played for atleast 2 hours preoperatively.
Other: Preoperative application of a bluetooth enabled Headphones.
A Bluetooth enabled Headphones device which is worn overhead and music can be played through it.

Active Comparator: No Music
Preoperative application of a Bluetooth enabled headphones with no music played and headphones will just mask the surrounding noise.
Other: Preoperative application of a bluetooth enabled Headphones.
A Bluetooth enabled Headphones device which is worn overhead and music can be played through it.




Primary Outcome Measures :
  1. Postoperative Pain (POP) [ Time Frame: 3 weeks ]

    Visual Analogue Scale (VAS) will be used to measure the pain on a numeric scale of 0-100 at 6 Hours, Day 1, Day 3, Day 10 and Week 3 postoperatively respectively with a total of 5 readings. Higher values on the VAS will represent a worse outcome.

    Minimum value on VAS = 0 Maximum value on VAS= 100


  2. Postoperative Nausea Vomiting (PONV) [ Time Frame: 3 weeks ]

    Visual Analogue Scale (VAS) will be used to measure the PONV on a numeric scale of 0-100 at 6 Hours, Day 1, Day 3, Day 10 and Week 3 postoperatively respectively with a total of 5 readings. Higher values on the VAS will represent a worse outcome.

    Minimum value on VAS = 0 Maximum value on VAS= 100


  3. Postoperative Fatigue (POF) [ Time Frame: 3 weeks ]

    Visual Analogue Scale (VAS) will be used to measure the pain on a numeric scale of 0-100 at 6 Hours, Day 1, Day 3, Day 10 and Week 3 postoperatively respectively with a total of 5 readings. Higher values on the VAS will represent a worse outcome.

    Minimum value on VAS = 0 Maximum value on VAS= 100


  4. Gastrointestinal Quality of Life Index (GIQoL) [ Time Frame: 1 month ]
    Gastrointestinal Quality Of Life Index (GIQoL) 30 Days Min=0 (Best) Max=144 (Worst) GIQoL will be assessed on 30th postoperative day and any difference in the measurement will be assessed for analysis in between the two study arms.


Secondary Outcome Measures :
  1. Liver function test (LFT) [ Time Frame: upto 24 hours after surgical intervention ]
    Tests will be done for 4 times (Preoperatively, Intraoperatively, 6 hours postoperatively, 24 hours postoperatively)

  2. Serum amylase [ Time Frame: upto 24 hours after surgical intervention ]

    Tests will be done for 4 times (Preoperatively, Intraoperatively, 6 hours postoperatively, 24 hours postoperatively)

    The difference in the values will be assessed as follows for all the testes:

    Preop-Intraop, Intraop-6H, 6H-24H


  3. Serum lipase [ Time Frame: upto 24 hours after surgical intervention ]

    Tests will be done for 4 times (Preoperatively, Intraoperatively, 6 hours postoperatively, 24 hours postoperatively)

    The difference in the values will be assessed as follows for all the testes:

    Preop-Intraop, Intraop-6H, 6H-24H


  4. Interlukin-6 (IL-6) [ Time Frame: upto 24 hours after surgical intervention ]

    Tests will be done for 4 times (Preoperatively, Intraoperatively, 6 hours postoperatively, 24 hours postoperatively)

    The difference in the values will be assessed as follows for all the testes:

    Preop-Intraop, Intraop-6H, 6H-24H


  5. Tumor Necrosis Factor-alpha (TNF -alpha ) [ Time Frame: upto 24 hours after surgical intervention ]

    Tests will be done for 4 times (Preoperatively, Intraoperatively, 6 hours postoperatively, 24 hours postoperatively)

    The difference in the values will be assessed as follows for all the testes:

    Preop-Intraop, Intraop-6H, 6H-24H


  6. HsCRP [ Time Frame: upto 24 hours after surgical intervention ]

    Tests will be done for 4 times (Preoperatively, Intraoperatively, 6 hours postoperatively, 24 hours postoperatively)

    The difference in the values will be assessed as follows for all the testes:

    Preop-Intraop, Intraop-6H, 6H-24H


  7. Serum Procalcitonin [ Time Frame: upto 24 hours after surgical intervention ]

    Tests will be done for 4 times (Preoperatively, Intraoperatively, 6 hours postoperatively, 24 hours postoperatively)

    The difference in the values will be assessed as follows for all the testes:

    Preop-Intraop, Intraop-6H, 6H-24H


  8. EEG [ Time Frame: upto 24 hours after surgical intervention ]
    Recording of EEg will be done at 3 separate occasions. Preoperatively, Intraoperatively and 24 hours postoperatively. EEG will be interpreted by a an independent evaluator for any changes who will be unaware of the timing of record of the EEG. The changes in the brain wave form will be seen and recorded for evaluation.

  9. LDH [ Time Frame: upto 24 hours after surgical intervention ]

    Tests will be done for 4 times (Preoperatively, Intraoperatively, 6 hours postoperatively, 24 hours postoperatively)

    The difference in the values will be assessed as follows for all the testes:

    Preop-Intraop, Intraop-6H, 6H-24H


  10. Uric Acid [ Time Frame: upto 24 hours after surgical intervention ]

    Tests will be done for 4 times (Preoperatively, Intraoperatively, 6 hours postoperatively, 24 hours postoperatively)

    The difference in the values will be assessed as follows for all the testes:

    Preop-Intraop, Intraop-6H, 6H-24H




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age more than 18 years.
  2. Should be able to understand and sign an informed consent.
  3. Consent for surgery, anaesthesia and the use of standardized music before surgery. (Appendix I)
  4. Fitness for General Anesthesia (GA)
  5. Ability to maintain & communicate a PRO diary.
  6. Ability to communicate via telephone or email or SMS or WhatsApp.

Exclusion Criteria:

  1. Fitfor GA but higher than ASA Grade I.
  2. Uncontrolled coagulopathy
  3. Suspicion of carcinoma gallbladder on USG
  4. Any suspicion of common bile duct (CBD) stones or pancreatitis.
  5. Patient using chronic anti-inflammatory drug.
  6. Concomitant common bile duct (CBD) stone or any CBD intervention/pancreatitis in the preceding 6 weeks.
  7. Patient on immunosuppressive / cytotoxic/ steroid therapy.
  8. Documented or known sensitivity to any drug to be used in the study protocol.
  9. Pregnant or lactating ladies.
  10. Any concomitant surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03429478


Contacts
Contact: Brij bhushan Agarwal, MS 9810124256 endosurgeon@gmail.com
Contact: Neeraj Dhamija, DNB 9811377332 neerajdhamija@icloud.com

Locations
India
Prof. Brij Bushan Agarwal Recruiting
Delhi, India, 110058
Contact: Neeraj Dhamija, DNB Surgery    +919811377332    neerajdhamija@icloud.com   
Sponsors and Collaborators
Sir Ganga Ram Hospital

Responsible Party: PROF. BRIJ B AGARWAL, Vice Chairman Department of General and Laparoscopic Surgery, Sir Ganga Ram Hospital
ClinicalTrials.gov Identifier: NCT03429478     History of Changes
Other Study ID Numbers: EC/10/17/1281
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Clinical and biochmical data

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by PROF. BRIJ B AGARWAL, Sir Ganga Ram Hospital:
Music
Laparoscopic Surgery
Sterile Inflammation

Additional relevant MeSH terms:
Genital Diseases, Female
Inflammation
Cholecystitis
Acalculous Cholecystitis
Cholelithiasis
Cholecystolithiasis
Gallstones
Infertility
Intraoperative Complications
Pathologic Processes
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Calculi
Pathological Conditions, Anatomical
Genital Diseases, Male